In my company, we have a matrix organization and I think it works pretty well. Each type of function (i.e. R&D, Quality, Manufacturing, Regulatory...

For my personality, I think I would be better suited for upper management. I am much more of a strategic, big-picture, planner type person than a day-...

Unfortunately, individuals don't always have a choice in who they work with on specific projects - this decision is usually left up to the managers. I...

Risks are typically identified and prioritized based on the critical quality attributes (CQAs) of the device. CQAs are the most important features of ...

I completely agree. You have to understand that the surgeons using these instruments are highly trained individuals that obviously know what they are ...

I completely agree, "As Far As Possible" is a pretty ambiguous term, which is why it is up to the medical device company to determine how far their ri...

Proper design controls ensure that the device will not fail in the field under expected usage conditions. Of course, there will always be someone who ...

Verification activities will be conducted to ensure all design outputs satisfy their design inputs. Design inputs are generally determined based on th...

This is a very common question, as these terms are often used confused with each other. Design verification is ensuring all of the design outputs meet...

Design controls are hugely important for several reasons. In the new product development world, many times the design inputs and performance requireme...

Well organized, detailed meeting minutes are extremely important to the product development process. When decisions are being made, it is necessary to...

Successfully executed design review meetings are crucial for the overall success of the project. Typically, specific deliverables will be defined that...

I think placebos are important in order to determine a baseline to compare the effects of the actual product against. While some people may argue givi...

In order to release a product to the public, clinical trials are absolutely necessary to understand the potential effects of the product on the human ...

In a double blind study, the investigator doesn't necessarily need to be blinded. Typically, I think it's necessary to blind the patient so they can't...